F.D.A. Is Unable to Ensure Drugs Are Safe, Panel Is Told
议员们被告知：F.D.A.不能保证药品是安全的。
The Food and Drug Administration cannot guarantee the safety of the nation’s drug supply because it inspects few foreign drug manufacturers and the inspections it does carry out abroad are less rigorous than those performed in this country, witnesses told a Congressional subcommittee yesterday.
F.D.A.不能保证供应到美国的药品是安全的因为它只对向美国出口药品的生产商中的一小部分进行审计，而且它实施的海外审计也不像国内审计那样的严格，这是昨天国会听证会上公布的证词。
While foreign companies manufacture as much as 80 percent of all ingredients used by American drug makers, the drug agency’s record keeping is so poor that it cannot say which of those have not been inspected, according to the testimony before the House Energy and Commerce Subcommittee on Oversight and Investigations.“More than nine years after we issued our last report on this topic, F.D.A.’s effectiveness in managing the foreign drug inspection program continues to be hindered by weaknesses in its data systems,” Marcia Crosse, director of health care for the Government Accountability Office, said in a statement to the committee.
根据众议院能源和商务委员会调查小组的证词：虽然美国药品生产商所需的药物成分有80%来自海外，但是监管部门在这方面的记录却非常有限，它们甚至说不清哪些是应当审计而没有被审计的企业。政府问责办公室负责健康事务的主管Marcia Crosse在委员会作证时说：“我们公布的最后一份有关这个问题的报告是在九年多之前，但是直到今天F.D.A.在数据体系方面的问题仍然成为它对海外审计项目进行有效管理的障碍。
The agency is supposed to inspect domestic drug makers every two years, but there is no such requirement for foreign suppliers, even though foreign factories are more likely to have quality problems, witnesses said . At the current rate, the agency would take more than 13 years to inspect each foreign establishment once — and those are just the factories it knows about, Ms. Crosse said.
Crosse女士还说：F.D.A.一般每两年要对国内的制药企业审计一次，但是对海外供应商也没有这样的要求，可是海外企业却更容易发生质量问题。按照现在的频率F.D.A.需要花13年以上的时间才能对每个海外企业都审计一次（这还只是那些已知的企业）。
The chairman of the subcommittee, Representative Bart Stupak, Democrat of Michigan, said Americans had “dodged a bullet” because no one died from using Chinese toothpaste containing diethylene glycol, a poison used in antifreeze. But Panamanians were not so fortunate, Mr. Stupak added, when the same poison from China ended up in cold medicine, killing dozens.
能源与商务委员会的主席Bart Stupak（密歇根州的民主党议员）说美国侥幸躲过了“冷枪”的袭击，因为目前还没有人死于中国生产的被二甘醇（一种有毒的防冻剂）污染的牙膏。但是巴拿马就没有这样幸运，从中国出口的二甘醇在巴拿马被作为辅料加入退烧药中导致数十人死亡。
“That can happen here, and it surely will,” Mr. Stupak said, unless the F.D.A. does a better job of overseeing foreign drug suppliers. Bart Stupak（密歇根州的民主党议员）说：除非F.D.A.在监管海外供应商方面做得更好，否则这样的事情将来一定会在美国发生。
Pharmaceutical manufacturers in the United States do not rely only on drug agency inspections of foreign suppliers to make sure drug supplies are safe. The companies also perform their own inspections and periodically test shipments to ensure quality. The agency also screens drug imports entering the country.
美国的药品生产企业并不完全依赖药监部门对海外企业的审计来确保药品供应的安全。这些企业自己也对海外企业进行审计并对产品进行周期性的检测以确保质量。药监部门也对进口的要求进行审查。
Several witnesses said their concerns about the quality of China’s drug ingredients had been heightened by an article on Wednesday in The New York Times. The article reported that China’s drug regulators did not certify or inspect chemical companies that often made and exported drug ingredients. Those companies, which may manufacture a multitude of items, including fertilizer and industrial solvents, are not required to meet even minimal drug-manufacturing standards, so there is little to stop them from exporting unapproved, adulterated or counterfeit ingredients.
根据《纽约时报》星期三的报道F.D.A.对中国药物成分质量问题的关注程度在增加。这篇文章报道中国的药品监管部门对经常生产和出口药物成分的化工企业却没有任何审计和认证。这些企业生产多种产品，例如：化肥、工业溶剂等等，但是却不要求达到最低的药品生产水平，它们出口未经批准的伪劣药物成分也没有多少限制。
The accountability office, the investigative arm of Congress, also found that the drug agency relied on volunteers to conduct foreign inspections and that inspections were often determined by travel schedules and not need.
作为国会的调查机构，政府问责办公室同样发现药监部门依赖志愿者进行海外审计，因此审计的时间经常根据志愿者的旅行计划而定。
Another problem, witnesses said, is that the agency gives foreign drug makers advance notice of inspections, in contrast to the unannounced inspections in the United States. In some cases, agency inspectors have to rely on the company being inspected to provide translators.
另一个问题，有证据显示药监部门对海外企业进行的审计是事先通知的，而不是像对美国国内的企业那样事先不通知，在一些审计过程中，审计官还要依赖被审计公司提供的翻译。
Dr. Andrew C. von Eschenbach, food and drug commissioner, said his agency was changing its collection and use of data and was working more closely with foreign governments, including China’s. “We recognize that the world is evolving and our local markets now provide products largely from a global marketplace。” he said, adding that the American drug supply is still among the safest in the world.
F.D.A.的局长Andrew C. von Eschenbach博士说他的部门正在对收集和使用资料的方式进行改变并且更好的与相关国家的政府机构（包括中国）合作，他说：“我们已经认识到世界正在更紧密的成为一体，现在美国市场上的产品大部分来自于国际市场，但是美国现在仍然是世界上药品供应最安全的国家。”
德国佬就是事多。。。
德国佬?
议员们被告知：F.D.A.不能保证药品是安全的。
The Food and Drug Administration cannot guarantee the safety of the nation’s drug supply because it inspects few foreign drug manufacturers and the inspections it does carry out abroad are less rigorous than those performed in this country, witnesses told a Congressional subcommittee yesterday.
F.D.A.不能保证供应到美国的药品是安全的因为它只对向美国出口药品的生产商中的一小部分进行审计，而且它实施的海外审计也不像国内审计那样的严格，这是昨天国会听证会上公布的证词。
While foreign companies manufacture as much as 80 percent of all ingredients used by American drug makers, the drug agency’s record keeping is so poor that it cannot say which of those have not been inspected, according to the testimony before the House Energy and Commerce Subcommittee on Oversight and Investigations.“More than nine years after we issued our last report on this topic, F.D.A.’s effectiveness in managing the foreign drug inspection program continues to be hindered by weaknesses in its data systems,” Marcia Crosse, director of health care for the Government Accountability Office, said in a statement to the committee.
根据众议院能源和商务委员会调查小组的证词：虽然美国药品生产商所需的药物成分有80%来自海外，但是监管部门在这方面的记录却非常有限，它们甚至说不清哪些是应当审计而没有被审计的企业。政府问责办公室负责健康事务的主管Marcia Crosse在委员会作证时说：“我们公布的最后一份有关这个问题的报告是在九年多之前，但是直到今天F.D.A.在数据体系方面的问题仍然成为它对海外审计项目进行有效管理的障碍。
The agency is supposed to inspect domestic drug makers every two years, but there is no such requirement for foreign suppliers, even though foreign factories are more likely to have quality problems, witnesses said . At the current rate, the agency would take more than 13 years to inspect each foreign establishment once — and those are just the factories it knows about, Ms. Crosse said.
Crosse女士还说：F.D.A.一般每两年要对国内的制药企业审计一次，但是对海外供应商也没有这样的要求，可是海外企业却更容易发生质量问题。按照现在的频率F.D.A.需要花13年以上的时间才能对每个海外企业都审计一次（这还只是那些已知的企业）。
The chairman of the subcommittee, Representative Bart Stupak, Democrat of Michigan, said Americans had “dodged a bullet” because no one died from using Chinese toothpaste containing diethylene glycol, a poison used in antifreeze. But Panamanians were not so fortunate, Mr. Stupak added, when the same poison from China ended up in cold medicine, killing dozens.
能源与商务委员会的主席Bart Stupak（密歇根州的民主党议员）说美国侥幸躲过了“冷枪”的袭击，因为目前还没有人死于中国生产的被二甘醇（一种有毒的防冻剂）污染的牙膏。但是巴拿马就没有这样幸运，从中国出口的二甘醇在巴拿马被作为辅料加入退烧药中导致数十人死亡。
“That can happen here, and it surely will,” Mr. Stupak said, unless the F.D.A. does a better job of overseeing foreign drug suppliers. Bart Stupak（密歇根州的民主党议员）说：除非F.D.A.在监管海外供应商方面做得更好，否则这样的事情将来一定会在美国发生。
Pharmaceutical manufacturers in the United States do not rely only on drug agency inspections of foreign suppliers to make sure drug supplies are safe. The companies also perform their own inspections and periodically test shipments to ensure quality. The agency also screens drug imports entering the country.
美国的药品生产企业并不完全依赖药监部门对海外企业的审计来确保药品供应的安全。这些企业自己也对海外企业进行审计并对产品进行周期性的检测以确保质量。药监部门也对进口的要求进行审查。
Several witnesses said their concerns about the quality of China’s drug ingredients had been heightened by an article on Wednesday in The New York Times. The article reported that China’s drug regulators did not certify or inspect chemical companies that often made and exported drug ingredients. Those companies, which may manufacture a multitude of items, including fertilizer and industrial solvents, are not required to meet even minimal drug-manufacturing standards, so there is little to stop them from exporting unapproved, adulterated or counterfeit ingredients.
根据《纽约时报》星期三的报道F.D.A.对中国药物成分质量问题的关注程度在增加。这篇文章报道中国的药品监管部门对经常生产和出口药物成分的化工企业却没有任何审计和认证。这些企业生产多种产品，例如：化肥、工业溶剂等等，但是却不要求达到最低的药品生产水平，它们出口未经批准的伪劣药物成分也没有多少限制。
The accountability office, the investigative arm of Congress, also found that the drug agency relied on volunteers to conduct foreign inspections and that inspections were often determined by travel schedules and not need.
作为国会的调查机构，政府问责办公室同样发现药监部门依赖志愿者进行海外审计，因此审计的时间经常根据志愿者的旅行计划而定。
Another problem, witnesses said, is that the agency gives foreign drug makers advance notice of inspections, in contrast to the unannounced inspections in the United States. In some cases, agency inspectors have to rely on the company being inspected to provide translators.
另一个问题，有证据显示药监部门对海外企业进行的审计是事先通知的，而不是像对美国国内的企业那样事先不通知，在一些审计过程中，审计官还要依赖被审计公司提供的翻译。
Dr. Andrew C. von Eschenbach, food and drug commissioner, said his agency was changing its collection and use of data and was working more closely with foreign governments, including China’s. “We recognize that the world is evolving and our local markets now provide products largely from a global marketplace。” he said, adding that the American drug supply is still among the safest in the world.
F.D.A.的局长Andrew C. von Eschenbach博士说他的部门正在对收集和使用资料的方式进行改变并且更好的与相关国家的政府机构（包括中国）合作，他说：“我们已经认识到世界正在更紧密的成为一体，现在美国市场上的产品大部分来自于国际市场，但是美国现在仍然是世界上药品供应最安全的国家。”
德国佬就是事多。。。
德国佬?